SignalMark 乳房标记
K号: K190689 · 2019-08-14
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决定日期2019-08-14
产品代码NEU
咨询委员会SU
请注意，您提供的文本“SU”不足以进行翻译。请提供完整的描述性文本以便进行翻译。
决定实质等同
器械摘要
SignalMark Breast Marker is the device name listed in this FDA 510(k) record. The listed applicant is View Point Medical, Inc.. It received FDA 510(k) clearance on 2019-08-14 under 510(k) number K190689. The device is classified under product code NEU. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the SignalMark Breast Marker?
SignalMark Breast Marker is a medical device that received FDA 510(k) clearance on 2019-08-14. The listed applicant is View Point Medical, Inc.. The 510(k) number is K190689.
When did SignalMark Breast Marker receive FDA 510(k) clearance?
SignalMark Breast Marker received FDA 510(k) clearance on 2019-08-14, under 510(k) number K190689.
Who is the listed applicant for SignalMark Breast Marker?
The FDA 510(k) record lists View Point Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for SignalMark Breast Marker?
The FDA product code for SignalMark Breast Marker is NEU.
相关临床试验
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
列明View Point Medical, Inc.为申报人的其他记录
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
相关器械（代码：NEU）
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
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官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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